MTN-039 is an open-label, multi-site single arm, two-period study designed to evaluate the safety and pharmacokinetics (PK) of elvitegravir (EVG) administered rectally as an insert at two dose levels. Elvitegravir is a potent inhibitor of HIV-1 integrase. Approximately 20 healthy, HIV-uninfected men and women (cis or transgender) who are 18 years of age and older who have a history of consensual receptive anal intercourse (RAI) will be enrolled in MTN-039. Participants will receive a single 8 mg EVG insert rectally, and samples will be collected over a three-day period. Following a washout period, participants will apply two 8 mg inserts rectally, with samples being collected over a three-day period. It is anticipated that this study will take approximately 6-8 months to enroll the target sample size, and that total study duration for participants will be between 6-13 weeks. It is hypothesized that one 8 mg EVG insert and two 8 mg EVG inserts will be safe and well-tolerated among healthy men and women, when a single dose of either study product is administered rectally under direct observation in the clinic.
Riddler, Sharon (Protocol Chair)
A Phase 1 Open Label Safety and Pharmacokinetic Study of Single Dose Rectal Administration of an Elvitegravir Insert at Two Dose Levels
DAIDS Protocol ID
Study Focus/Product Administration
Men (cisgender men, non‐transgender men)
Women (cisgender women, non‐transgender women)